Open AccessDevelopment and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method
Author(s) -
Т. Н. Комаров,
И. Е. Шохин,
М. А. Токарева,
О. А. Арчакова,
Д. С. Богданова,
А. В. Алешина,
Н. С. Багаева,
В. В. Давыданова
Publication year - 2021
Publication title -
razrabotka i registraciâ lekarstvennyh sredstv
Language(s) - English
Resource type - Journals
eISSN - 2658-5049
pISSN - 2305-2066
DOI - 10.33380/2305-2066-2021-10-1-120-128
Subject(s) - valganciclovir , ganciclovir , chromatography , high performance liquid chromatography , protein precipitation , chemistry , pharmacokinetics , detection limit , active metabolite , metabolite , human cytomegalovirus , pharmacology , medicine , biochemistry , gene
. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatographic separation of so-called poorly retained compounds – drug substances poorly retained on the chromatographic column. Valganciclovir and Ganciclovir are among such substances. Aim. The aim of this study is to develop a method for valganciclovir and ganciclovir in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies. Materials and methods. Determination of valganciclovir and ganciclovir in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation. Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over and stability. Conclusion. The method of the determination of valganciclovir and ganciclovir in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 5.00–1000.00 ng/ml for valganciclovir and 50.00–10000.00 ng/ml for ganciclovir. Method could be applied to valganciclovir and ganciclovir determination in plasma for PK and BE studies.